Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
FDA adverse event reports and recall history for monitor, physiological, patient (without arrhythmia detection or alarms) (product code MWI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,899
- Deaths
- 45
- Injuries
- 113
- Malfunctions
- 1,722
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-03-11Open, ClassifiedUnder Investigation by firm
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
- 2026-01-22Open, ClassifiedDevice Design
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
- 2025-07-02Open, ClassifiedSoftware design
Change Healthcare Cardiology Hemo Software
Due to complaints, software update may cause software to unexpectedly shutdown.
- 2025-07-02Open, ClassifiedSoftware design
Change Healthcare Cardiology Hemodynamics Software
Due to complaints, software update may cause software to unexpectedly shutdown.
- 2025-04-29Open, ClassifiedNo Marketing Application
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.
Medical device software marketed without FDA clearance .
- 2025-04-29Open, ClassifiedNo Marketing Application
Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.
Medical device software marketed without FDA clearance .
- 2025-04-15Open, ClassifiedDevice Design
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-14Open, ClassifiedProcess design
Welch Allyn CONNEX Accessory Power Management Stand:
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
- 2025-01-16Open, ClassifiedSoftware design
McKesson Cardiology Hemo software
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
- 2025-01-16Open, ClassifiedSoftware design
Change Healthcare Cardiology Hemo software
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Monitor monitor, physiological, patient (without arrhythmia detection or alarms) automatically
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